AmpFire HPV和ScreenFire RS HPV验证试验中的两种药物.
Jun Hou1,2,3, Jerome L Belinson4,5, Hui Du1,2,3
1Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen, China.
American journal of clinical pathology
|February 16, 2024
概括
新的人类乳头瘤病毒 (HPV) 查试验显示出高准确性和可重复性. 这些经过验证的HPV测试适用于资源较少的环境,改善了宫癌查的可访问性.
科学领域:
- 分子诊断学 分子诊断学
- 妇科瘤学 妇科瘤学
- 公共卫生 公共卫生
背景情况:
- 宫癌查依赖于精确的人类乳头瘤病毒 (HPV) 检测.
- 现有的HPV测定需要对各种临床环境进行验证,特别是低资源环境.
- 阿提拉生物系统公司开发了新的HPV查试验,AmpFire和ScreenFire RS,以提高检测能力.
研究的目的:
- 为了验证Atila Biosystems的AmpFire和ScreenFire RSHPV查试验的临床性能和可重复性.
- 通过使用临床终点来评估这些测试的诊断准确性,与使用临床终点的既定方法对比.
- 评估这些试验是否适合在资源有限的环境中实施.
主要方法:
- 验证了556个自收集的标本来自中国多站点查试验对科巴斯4800和SeqHPV.
- 包括已确认高风险HPV (hrHPV) 阳性和宫内皮质瘤 (CIN2+) 终点的样本.
- 模拟VALGENT框架用于实验室内和实验室内验证,包括对ScreenFire RS试验的层次评估.
主要成果:
- 两种AmpFire和ScreenFire测定检测到98.1%的CIN2或更高的病例.
- 高的实验室内 (95.13%-96.03%) 和实验室间 (93.68%-94.04%) 对整体 hrHPV检测的一致性.
- 对于ScreenFire RS,基因型特定一致性和临床指导评估非常出色, κ值高 (0.86-0.94).
结论:
- AmpFire和ScreenFire RS测试显示出出色的临床性能和可重复性.
- 这些HPV检测的简单性和可靠性使得它们在缺乏资源的环境中非常适用于宫癌查.
- 这些验证的试验为改善全球HPV检测和管理策略提供了有希望的工具.
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